Section 16: Other exclusions

(1) Human beings, and biological processes for their generation, are not patentable inventions.

(2) An invention of a method of treatment of human beings by surgery or therapy is not a patentable invention.

(3) An invention of a method of diagnosis practised on human beings is not a patentable invention.

(4) A plant variety is not a patentable invention.

(5) For the purposes of subsection (4), plant variety has the same meaning as that given to the term variety in section 2 of the Plant Variety Rights Act 1987.

Patentability of human beings

1. Section 16(1) of the Patents Act 2013 provides that human beings, and biological processes for their generation, are not patentable inventions.

2. Section 16(1) is the same as s18(2) of the Australian Patents Act 1990. There have been no rulings from the Australian courts on what is, or is not patentable under s18(2). There have, however, been two decisions of the Australian Commissioner of Patents on this issue - Fertilitescentrum AB and Luminis Pty Ltd [2004] APO 19 (‘Fertilitescentrum’) and Woo-Suk Hwang [2004] APO 24. In the absence of any other guidance, these guidelines are based on these decisions.

Patentability of human beings under the Patents Act 1953

3. Practice under the Patents Act 1953 is that claims that include human beings, processes which give rise to human beings, and biological processes for their production will be refused under section 17(1) of the Patents Act 1953, on the ground that use of the invention would be contrary to morality.

4. This practice will not change under s16(1) the Patents Act 2013, however the effect of s16(1) is to codify this practice.

What constitutes a human being for the purposes of s16(1)?

5. The claims at issue in Fertilitescentrum were claims to a method of growing preblastocyst human embryos. As the claims related to human embryos, they there was no question that they related to a human life form. The question was whether they related to human beings (emphasis added).

6. In deciding this question, the hearing officer considered three approaches to this issue.

i. What point does a human being come into existence?

ii. Focus on the ‘wrong’ that Parliament was trying to address; and

iii. Specifying the start and end points of the period in which a human being is generated.

7. Of these, the hearing officer considered that the third approach was the most appropriate. After considering the issues, the start of the period in which a human being is generated was defined as the time of fertilisation; that is, when the sperm enters the ovum - for at that time the ovum has all it needs to go on and develop as a human being (paragraph 32 of Fertilitescentrum).

8. The definition of the end point of the process was less clear cut to the hearing officer. However, again after considering the issues, he defined the end of the process as birth – on the grounds that this is when the full status of human being is acquired (paragraph 35 of Fertilitescentrum). He went on to state:

“The prohibition of `human beings' in my view is a prohibition of patenting of any entity that might reasonably claim the status of a human being. Clearly a person that has been born is covered by this exclusion. But to the extent that there is a process of generation of a human being that lasts from fertilisation to birth, I consider that a fertilised ovum and all its subsequent manifestations are covered by this exclusion.”

9. On this basis, the human embryos that were the subject of the claims at issue were considered to be human beings.

10. The claims dealt with in Fertilitescentrum dealt with human embryos originating from ova fertilised by a sperm through an in vitro fertilisation process. However, fertilisation is not necessarily the only way to activate an ovum so that it will develop into a human being.

11. The patent application dealt with in Woo-Suk Hwang differed in two significant ways from that in Fertilitescentrum. First, there was no actual fertilisation process, and second, the embryo was a hybrid, with human nuclear DNA and bovine mitochondrial DNA.

12. Notwithstanding these differences, the hearing officer considered that the ovum from which the embryo originated was human (see paragraph 8 of Woo-Suk Hwang):

“In natural reproductive processes, the activation of an ovum arises as a direct result of the fertilisation process. However it is clear that fertilisation by a sperm is not the only way in which an ovum can be activated. In my view, an ovum that has been artificially activated is in principle no different to an ovum that has been fertilised by natural means (noting of course that the DNA content of the ovum will be different.) Accordingly the fact that the claimed method uses postactivation of the ovum does not remove the process from the ambit of s.18(2).”

13. The hearing officer also concluded that the embryo produced by the method claimed in the application was human. This was on the basis that the essential characteristics of the embryo were determined by the nuclear DNA – the embryo was therefore properly described as human regardless of the presence of non-human mitochondrial DNA (see paragraph 9 of Woo-Suk Hwang.

14. It follows from this that any entity that might claim the status of a human being is ineligible for patent protection under s16(1). This includes:

• Human ova that have been fertilised or activated by any means;
• Human zygotes, blastocysts, embryos and foetuses; and
• totipotent human cells, including those cells that are the products of nuclear transfer procedures.

Biological processes for the production of human beings

15. In general, biological processes that would lead to the production of any entity that might claim the status of a human being would be considered to constitute processes for the production of a human being. These include (as listed in s 2.9.5 of the IP Australia patent examiners’ manual):

• methods of in vitro fertilisation;
• processes for intracytoplasmic sperm injection;
• processes for cloning at the 4-cell stage;
• processes for cloning by replacing nuclear DNA;
• processes or methods of growing or culturing fertilised ova, zygotes or embryos etc; and
• processes or methods for introducing transgenes and donor genetic or donor cytoplasmic material into fertilised ova, zygotes or embryos etc.

16. Any method or process that involves the creation of a human embryo will be ineligible for a patent even if the embryo is not the final product of the method. For example, a method of producing human stem cells which includes a step or steps of creating a human embryo would be excluded. This is the case regardless of how the embryo is created.

Human Assisted Reproductive Technology Act 2004

17. Schedule 1 of the Human Assisted Reproductive Technology Act 2004 prohibits certain actions relating to cloned embryos or human embryos. The fact that a claim may include within its scope an act prohibited by this Act is not, in itself, a justification for refusing the claim under s16(1). Note that this is different from the situation in Australia where s50(1)(a) of the Patents Act 1990 provides that a patent may be refused if an invention is ‘contrary to law’. There is no corresponding provision in the Patents Act 2013.

However, the fact that a claim includes actions prohibited by the Human Assisted Reproductive Technology Act 2004 may be relevant to an objection under s15 of the Patents Act 2013.

Methods of treatment by therapy or surgery, or methods of diagnosis performed directly on the human body

Introduction

18. Sections 16(2) and 16(3) of the Patents Act 2013 state:

(2) An invention of a method of treatment of human beings by surgery or therapy is not a patentable invention.

(3) An invention of a method of diagnosis practised on human beings is not a patentable invention.’

19. This effectively codifies the situation under the Patents Act 1953, where the Court of Appeal in Pfizer Inc v Commissioner of Patents [2005] NZLR 362 held that methods of medical treatment of humans did not meet the definition of ‘invention’ under the Act. As a result, claims to methods of treatment of humans by therapy or surgery, and methods of diagnosis practiced directly on human beings were not accepted under the Patents Act 1953.

 20. Sections 16(2) and 16(3) of the Patents Act 2013 have similar wording to s4A(1) of the United Kingdom Patents Act 1977 – the main difference is that the United Kingdom provision also excludes methods of treatment and diagnosis of animals as well as humans. In light of this, these guidelines are based on the approach taken in the United Kingdom Intellectual Property Office Manual of Patent Practice but only to the extent that they apply to methods involving human beings.

Methods of treatment by therapy

Definition of ‘therapy’

21. The definition of ‘therapy’ includes treatments that both cure or prevent disease. It also includes methods of alleviating symptoms of a disease. In Unilever (Davis’) Application [1983] RPC 19, it was held that therapy should be construed as the medical treatment of disease, including curative and preventative treatments.

 22. The European Patent Office, in its decisions T24/91 THOMPSON/Cornea OJEPO 1995, 512 and T 58/87 SALMINEN/Pigs III [1989] EPOR 125 58/87 provided a useful definition of ‘therapy’:

 ‘...any treatment which is designed to cure, alleviate, remove or lessen the symptoms of, or prevent or reduce the possibility of contracting any disorder or malfunction of the animal body’

Form of claims

23. As with any claim, it is the substance of what is claimed that ultimately determines patentability, rather than the actual form of words used. While claims of the form:

‘A method of treating medical condition X by administering substance Y’, are clearly claims to methods of treatment by therapy, other forms of claim can also be considered claims to methods of treatment by therapy.

24. The following forms of claim are considered to relate to methods of treatment by therapy (see John Wyeth’s and Schering’s Application [1985] RPC 545) and will not be accepted:

i. The treatment of (medical condition Y) with (substance X).

ii. The use of (substance X) to treat (medical condition Y).

iii. (Substance X) when used to treat (medical condition Y).

iv. The use of (substance X) as a pharmaceutical.

25. Example (iv) above is interpreted as a claim to the pharmaceutical in a method of treatment as opposed to a claim to its use in a pharmaceutical formulation.

When is a method “treatment by therapy”?

26. One indicator that a method is a method of treatment by therapy is whether the method would normally be carried out by a medical professional. One of the justifications behind s16(2) and (3) is to avoid the possibility that medical professionals (or anyone else) could be restrained or prevented from using their professional skills by fear of infringing a patent.

27. If the nature of a method of treatment is such that it can only be performed by or under the supervision of a medical professional, it is probably a method of therapy and not patentable. However, claimed methods which do not affect a medical professional’s discretion may well fall outside the definition of a method of treatment by therapy.

28. The fact that a method must be carried out by a medical professional does not necessarily mean that it is a method of treatment by therapy. If a method has no therapeutic effect, such as collecting blood or other bodily fluids for analysis, the fact that it must be carried out by a medical professional does not mean that it is unpatentable.

29. On the other hand, the fact that a method can be carried out by someone other than a medical professional does not mean that it is not a method of treatment by therapy. Ultimately it is the purpose and inevitable effect of the claimed invention that is important. For example, a method of resuscitation that can be carried out by any person may be unpatentable even though a medical professional is not involved.

Claims including both therapeutic and non-therapeutic methods

30. Some claims may include within their scope methods that are therapeutic (unpatentable) and methods that are not (patentable). An example of this is a method that can be used on both humans (not patentable) and animals (patentable). Another might be a method for inhibiting the coagulation of blood by treating the blood with a compound X. If the treatment is applied to the blood while circulating in the patient the method is not patentable. If it is applied to blood stored outside the body, for example for transfusion purposes), it is not a method of therapy and hence patentable.

31. In such cases the claims will need to be amended to ensure that only patentable subject matter is claimed. No amendment will be required if the specification makes it quite clear that the claims only relate to non-therapeutic methods.

32. Where it is apparent from the specification that the method relates to both therapeutic and non-therapeutic methods, the claims will need to be amended to limit the claims to patentable methods. The specification will also need to be amended to make it clear that therapeutic methods are not part of the invention.

33. If the claims are amended to limit them to patentable methods, examiners should ensure that there is adequate support for this in the specification. For example if claims are limited to non-therapeutic methods, then there must be some disclosure of the use of the method in a non-therapeutic setting. If there is not, the claim is bad for lack of support. The amendment may also constitute new matter, and therefore only be allowable with postdating.

34. This issue was dealt with in ICI (Richardson’s) Application [1981] FSR 609 where there was a claim to a method of producing an anti-oestrogenic effect in a human. The claim excluded any method that was a method of treatment by therapy. It was held, though, that the specification did not describe any application of the method other than for the treatment of breast cancer or infertility. On this basis the claim was rejected.

35. Amendments that limit the claim to ‘cosmetic’ or ‘non-therapeutic’ methods will be acceptable, subject to the condition set out earlier that there is sufficient support in the disclosure for claims to such methods. Any amendment that excludes therapeutic methods must ensure that the scope of what is actually being claimed is clear. Merely using the words in the Act to exclude therapeutic methods is not considered to provide sufficient clarity.

36. In some cases it may not be possible to separate the therapeutic and non-therapeutic effects of a claimed method. If the non-therapeutic effect is inseparable from the therapeutic effect, or if it is merely a secondary consequence of the therapy, then the invention is unpatentable, regardless of the claim wording used.

37. For example, a method of removing plaque from teeth will be unpatentable as removal of plaque will inevitably have the therapeutic effect of preventing tooth decay and gum disease. Claiming the method as a ‘cosmetic’ method will not change this, as, however claimed, the method will always have a therapeutic effect that cannot be separated from any cosmetic effect. See Oral Health Products (Halsteads) Application [RPC] 612, and Lee Pharmaceuticals’ Applications [1975 RPC 511, and ICI’s Application BL O/73/82.

38. If it is possible to separate the therapeutic and non-therapeutic effects of a method, then the fact that the method has a possible therapeutic use will not prevent it from being patented. An example of this is a treatment that could be cosmetic or therapeutic depending on the person being treated.

39. This approach was accepted in the case of an appetite suppressant, where its use in the treatment of obesity (a therapeutic method) did not prevent it from being patented for use in weight loss (cosmetic) – see T 144/83 DU PONT/Appetite suppressant OJEPO 1986, 30. A similar approach was taken in the case of an anti-bacterial treatment – see T 36/83 ROUSSEL-UCLAF/Thenoyl peroxide OJEPO 1986, 295.

Examples of therapeutic and non-therapeutic methods

Cosmetic treatments

40. Methods that produce purely cosmetic effects, such as cosmetic treatments of the skin and hair are patentable. These may include methods for strengthening nails (see Joos v Commissioner of Patents [1973] RPC 59. Methods for preventing hair loss may be cosmetic and patentable where the hair loss is due, for example, to the normal aging process, but may be therapeutic and unpatentable if the hair loss is caused by disease or a side-effect of another therapeutic method (such as radiotherapy). Methods of removing wrinkles caused by aging have no therapeutic effect, so a cosmetic method of removing wrinkles by phototherapy is patentable (Vurulite’s Application BL O/058/10).

Oral or dental care

41. Methods for the removal of dental plaque, or preventing its formation are regarded as therapeutic and not patentable. All such methods will have the effect of preventing or treating tooth decay, and patents for such methods were refused under the 1953 Act. As mentioned in paragraph 0, the inherent therapeutic effect of such methods cannot be separated from any cosmetic effect, so such methods are not patentable even if claims to them are restricted to cosmetic methods.

Relief of pain or fatigue

42. Methods for the relief or treatment of pain are considered to be methods of therapy, regardless of the origin of the pain as stated in T81/84 RORER/Dysmenorrhea OJEPO 1988, 202:

“Irrespective of the origin of pain, discomfort or incapacity, its relief, by the administration of an appropriate agent, is to be construed as ‘therapy’...”

43. It does not follow from this that all methods for the alleviation of discomfort are necessarily therapeutic. Methods for reducing the perception of fatigue, for example fatigue resulting from exercise could be considered to be non-therapeutic when carried out on a healthy person. On the other hand, such methods, when carried out to alleviate symptoms of an underlying health problem may be therapeutic – see T 469/94 MIT.

44. Methods for treating drug addiction, or withdrawal symptoms, including methods to help people stop smoking, are considered to be methods of therapy.

Treatment of obesity, weight reduction and fitness

45. Where weight reduction is for purely cosmetic reasons, claims to weight loss methods may be patented. Such methods may, of course, also be used for therapeutic purposes, for example, the treatment of obesity. If they are to be patentable, claims to such methods must be limited to use for cosmetic purposes only.

46. A method for ‘enhancing skeletal muscle performance of normal healthy subjects’ was considered to be non-therapeutic by virtue of its limitation to healthy subjects – see T 1230/05 BIOENERGY.

Methods of contraception, abortion, and fertility treatment

47. Methods of abortion, termination of pregnancy, or induction of labour will always be carried out under medical supervision. They are therefore considered methods of medical treatment of human and not patentable – see Upjohn (Kirton’s) Application [1976] RPC 324.

48. Pregnancy is not an illness or disease, so its prevention is not regarded as ‘therapy’ – see Schering’s Application [1971]RPC 337. Contraceptive methods may still be excluded from patenability if they also include a therapeutic element – see T 820/92 GENERAL HOSPITAL/Contraceptive method OJEPO 1995, 113.

49. Methods for the treatment of infertility in humans, including methods of in vitro fertilisation are considered methods of therapy and not patentable. Methods of implantation of human embryos fertilised in vitro are considered methods of surgery and also not patentable. Such methods may also constitute a ‘commercial and industrial’ use of a human embryo and may attract an objection under s15(1) of the Act.

Methods using implanted devices

50. If a claimed method has a therapeutic use then it is not patentable under s16(2). This applies even if the method involves a non-living object such as an implant. On this basis, a method of operating a heart pacemaker to regulate heartbeat is a method of therapy – see T 82/93 TELECTRONICS/Cardiac pacing OJEPO 1996, 274.

51. However, a method of controlling the energy input to a pacemaker so as to minimise energy consumption that does not affect the pacemaker’s output to the heart may be acceptable – see T 789/96 ELA MEDICAL/Therapeutic method OJEPO 2002, 364. Similarly, a method of measuring the flow of a drug or other substance from an implant, but which does not involve controlling the flow, has been held to be non-therapeutic – see T 245/87 SIEMENS/Flow measurement OJEPO 1989, 171.

52. Methods for the implantation of devices within the body are always unpatentable as this will always involve an invasive procedure. A similar comment applies to methods of controlling surgical devices, for example, surgical robots, in a way that impacts the body, by, example making an incision.

53. If methods for the internal operation of implanted devices do not impact on the body and do not relate to implantation, they may be patentable. The fact that a device must be implanted by surgery does not, in itself, mean that any method of operating the device is unpatentable. However, if the operation of the device involves surgery as an essential step (as opposed to a necessary pre-requisite), disclaiming or omitting the surgical step may lead to an objection under 39(1) – see G 01/07 MEDI-PHYSICS/Treatment by surgery OJEPO 2011, 134.

54. It was also held in G01/07 that methods that may assist a surgeon during surgery, such as a real-time imaging method are not methods of surgery as such.

Treatments performed outside the body

55. The fact that a method of therapeutic treatment of humans is performed outside the body does not avoid the exclusion in s16(2) of the Act. Examples of such methods are dialysis treatment or filtration methods. – see Calmic Engineering’s Application [1973] RPC 684, and Schultz’s Application BL O/174/86. It should be noted here that the exclusion for methods of therapy in s16(2) of the Act is not limited to methods ‘practised on human beings’ – this wording only appears in s16(3).

56. Methods of treating blood outside the human body are only considered ‘therapy’ if the blood is returned to same body. For example, dialysis treatment will therefore be unpatentable, but the treatment of blood for storage in a blood bank may be patentable.

Treatment of parasite infestation

57. The treatment or prevention of parasite infestation, either internal or external in human beings is considered a therapeutic method and not patentable. The argument that it is not therapy because the host human is not affected and only the parasite has been killed has been rejected – see Ciba-Geigy’s Application BL O/35/85.

58. Methods for the treatment of parasites on the skin of a human are considered therapy regardless of whether the parasites are ‘permanent’ or ‘temporary’. On this basis, methods of treatment for head lice are considered therapeutic and unpatentable, despite the decision in Stafford Miller’s Application [1984] FSR 258.

Surgery

Definition of surgery

59. The Oxford English dictionary defines surgery as the treatment of the body by incision or manipulation. It is not limited to actually cutting the body, but also includes manipulative methods of setting broken bones or relocating dislocated joints. It also includes dental surgery.

60. A method of implanting a human embryo can still be considered surgery even if it does not involve making an incision – see Occidental Petroleum’s Application [1973] RPC 684. Other methods of implanting devices into bodily cavities such as the lungs that do not require incision have been considered to be surgical methods by the European Patent Office – see T 05/04 CAMTECH.

61. While there is no authoritative definition of ‘method of surgery’ in the context of s16(3), the European Patent Office Enlarged Board of Appeal did provide some useful guidance on whether a particular method could be considered a method of surgery – see G 01/07 MEDI-PHYSICS/Treatment by surgery OJEPO 2011, 134. The Board of Appeal stated that a method should be excluded if:

"A … method … comprises or encompasses an invasive step representing a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise, is excluded from patentability as a method for treatment of the human or animal body by surgery"

Accordingly the following concept was developed by the Board of Appeal:

"In order to be excluded from patentability a method should involve a non-insignificant intentional physical intervention which is sufficiently invasive, and which entails a substantial health risk even when carried out with professional medical expertise (by a medical professional) on a human body”

62. On this basis, factors that examiners should consider when considering whether a claimed method relates to a method of surgery include:

i. Is the method invasive?

ii. Does it require professional skill?

iii. Is there a potential risk even when carried out by a medical professional?

63. Taking these factors into account, methods for taking blood samples, or injection methods would not generally be considered methods of surgery as they require little skill and involve low risk. If a method requires more specialist medical skills, such as lumbar puncture, it will probably not be patentable. In deciding whether a method is surgical, it is the risk of the invasive procedure itself that must be considered, not any side-effects of the procedure.

Surgery defined by nature of treatment

64. When deciding whether a method is a method of surgery, it is the nature of the method rather than its purpose that is the deciding factor. Methods of cosmetic surgery or other non-therapeutic surgery are still methods of surgery for the purposes of s16(3) and are not patentable:

“...surgery can be curative of the disease or diseased conditions, or prophylactic, that is, preventative of diseased conditions, as for example, where an appendix or tonsils may be removed before any diseased condition starts up, and surgery may even be cosmetic without being curative or preventative. So that the subsection it seems to me is saying that any method of surgical treatment, whether it is curative, prophylactic or cosmetic, is not patentable.” –

65. See Unilever (Davis’s) Application [1983] RPC 219 (Note - remarks on surgery were obiter).

Who carries out the method?

66. Whether a method is excluded as a method of surgery does not depend on who carries it out. A method that is or must be carried out by a surgeon is likely to be excluded as a method of surgery (see Occidental Petroleum’s Application [1973] RPC 684. Methods carried out by other medical professionals, such as dentists, paramedics, and nurses may still be regarded as methods of surgery.

67. If a method that may involve incision or manipulation of the body can be carried out by people who are not medical professionals, these would not generally be excluded. So, for example methods of tattooing the body, or for ear-piercing would be allowable. Tasks which otherwise might be considered surgery, but which have low risk, or are carried out on a routine basis, such as a method for collecting blood samples, may be patentable – see T 663/02 PRINCE.

68. Setting of bones is normally carried out by medical professionals and is unpatentable as a method of surgery. The making and applying of plaster casts would not normally be considered surgery as this work is normally done by a technician rather than a medical professional.

Methods of diagnosis

Definition

69. Diagnosis involves the determination of the nature of a medical condition, usually by investigating its nature and conducting tests. The act of diagnosis itself is an intellectual exercise which is not a manner of manufacture and is not patentable. Diagnosis can include a finding that a person does not have a particular condition, as well as a positive finding that the person has a disease - see T 807/98 ST JUDE. However, determination of a person’s general condition, such as their general state of fitness is not diagnostic if it is not intended to determine whether the person is suffering from a medical condition.

Methods of diagnosis

70. Diagnosis generally involves carrying out a series of steps that contribute towards the identification of a medical condition. The EPO Enlarged Board of Appeal suggested that these could be characterise as (see G 01/04 Diagnostic methods OJEPO 2006, 334):

i. the examination and collection of data;

ii. comparison of the data with normal values;

iii. recording any deviation from the norm; and

iv. attributing the deviation to a particular medical condition(s).

71. If a method includes all of these steps, so that it is possible to determine a course of treatment, it is clearly a method of diagnosis. In practice if a method includes only the first and last steps, it can be assumed that the second and third steps have also been carried out.

72. Where a method includes steps which assist in diagnosis, but which do not, by themselves allow a full diagnosis to be made it is not considered to be a method of diagnosis and claims to such methods may be allowable. Examples include methods of internal imaging, or methods of taking samples for in vitro analysis. If a method does not include all the steps to enable a diagnosis to be made, it is not a method of diagnosis:

“The method steps to be carried out prior to making a diagnosis as an intellectual exercise… are related to examination, data gathering and comparison…. If only one of the preceding steps which are constitutive for making such a diagnosis is lacking, there is no diagnostic method, but at best a method of data acquisition or data processing that can be used in a diagnostic method…”, see G 01/04 Diagnostic methods OJEPO 2006, 334.

73. Methods of data acquisition and processing may be objectionable on other grounds, for example they may not constitute a ‘manner of manufacture’, or may relate to a computer program ‘as such’.

74. Methods that are performed on the body that do not, in themselves, enable a medical condition to be identified are not considered diagnostic methods and will, in general, be allowable. Examples include CT scanning, the measurement of blood glucose, and methods of assessing tissue viability.

75. Methods which include all the steps necessary to make a diagnosis are excluded and should be objected to under s16(3). Where a claimed method relates to the diagnosis of a specific condition, it is clearly a method of diagnosis. In some cases, the claims may not specify a particular medical condition, but it may be clear from the complete specification that the method does, in fact relate to a method of diagnosis. For example, if a method allows a specific course of treatment to be identified, even though a specific medical condition is not mentioned, it is likely to be a method of diagnosis – see T 125/02 AEROCRINE.

76. There may be cases where essential steps of a method may be omitted (including the final step of attributing a deviation to a particular medical condition). In such cases the claims may not adequately define the invention and objection should be taken under s39 of the Act. This does not mean that every detail of a method must be set out in the claims. For example, where a method is performed in vitro the process of obtaining a sample from the body need not be explicitly included (unless the invention lies in the process for obtaining the sample).

When is a method of diagnosis ‘practised on the body’?

77. The exclusion for methods of diagnosis in s16(3) of the Act is limited to methods ‘practised on the body’. Tests that are performed outside the body, such as in vitro tests are patentable. Further only tests carried out on a living human being are unpatentable, so methods for determining cause of death carried out on dead bodies are also patentable.

78. For a method to be excluded because it is ‘practised on the body’ all of the physical steps of the method must be performed on the body. If a method involves both in vivo and in vitro steps, then the method as a whole is not considered to be practised on the body:

“if… some or all of the method steps of a technical nature… are carried out by a device without implying any interaction with the human or animal body, for instance by using a specific software program, these steps may not be considered to satisfy the criterion “practised on the human or animal body”, because their performance does not necessitate the presence of the latter. By the same token, this criterion is neither complied with in respect of method steps carried out in vitro in a laboratory.” G 01/04 Diagnostic methods OJEPO 2006, 334.

79. Of the steps set out in paragraph 70, the first, the examination and collection of data, is the only one that can actually be ‘practised on the body’, and is, in most cases the only ‘physical’ step. The final step is purely intellectual in nature, and the other steps will not, in most cases, be considered to be ‘physical’ steps, and so are not taken into account when determining whether a method is ‘practised on the body’. Steps that are preparatory steps, or additional to the steps set out in paragraph 70 are irrelevant, even if they are physical steps performed outside the body – see T 1197/02.

Nature of the person who performs the method

80. The question of whether a claimed method is a method of diagnosis is not dependent on who carries out the method, or whether a doctor is present:

‘whether or not a method is a diagnostic method within the meaning of Article 52(4) EPC should neither depend on the participation of a medical or veterinary practitioner, by being present or by bearing the responsibility, nor on the fact that all method steps can also, or only, be practised by medicinal or non-medicinal support staff, the patient himself or herself or an automated system.” G 01/04 Diagnostic methods OJEPO 2006, 334.

In vivo testing of drugs

81. In vivo testing of drugs to determine efficacy and safety would not normally be considered methods of diagnosis.

Multi-step methods involving at least one surgical, therapeutic and diagnostic step

82. Any multi-step method that includes at least one surgical, therapeutic or diagnostic step is excluded from patentability – see G 01/07 MEDI-PHYSICS/Treatment by surgery OJEPO 2011, 134.

83. The principle described in paragraph 82 that the presence in a claim of one excluded surgical, diagnostic or therapeutic step renders the whole claim unpatentable does not apply to methods of diagnosis practised on the body. Diagnostic methods are inherently multi-step methods, and are only excluded if they include all the steps required to make a diagnosis, and the new and inventive physical steps are practised on the body.

Apparatus used in surgical, therapeutic or diagnostic methods

84. While claims to medical apparatus per se are allowable, claims to such apparatus ‘when used’ in a method of surgery, therapy or diagnosis practised on the body are not allowable. Such claims are effectively claims to methods of surgery, therapy or diagnosis and cannot derive novelty or inventive step from the intended method of use – see Visx v Nidex [1998] FSR 405.

85. An implanted piece of apparatus, or assembly of items, which can only be constructed inside the body in a process involving a surgical step is not patentable, as such a claim is effectively a claim to a method of surgery even if it is framed as a product claim.

“...no European patent can be granted with claims directed to a new and even possibly inventive way of using devices, in particular endoprostheses, involving a treatment by surgery. This is equally true in the case of product claims defined by a construction which is only arrived at in the human or animal body following a surgical method step.” T 775/97 EXPANDABLE GRAFTS/Surgical device [2002] EPOR 24.

86. While the use of a device in a method surgery, therapy or diagnosis is unpatentable, this does not, in itself, mean that functional features in a claim to a product or apparatus is also unpatentable. Claims of this sort may, however be objectionable on other grounds, as defining the invention by a desired result, rather than by the physical features of the product or apparatus.

Patentability of plant varieties

87. Section 16(4) of the Patents Act 2013 states: A plant variety is not a patentable invention.

88. Plant varieties can be protected under the Plant Variety Rights Act 1987. To be eligible for a plant variety right a plant variety must be new, distinct from existing varieties, homogeneous and stable.

89. Plant variety rights can only be granted for new varieties of plants. The term plant variety as used in s16(4) has the same meaning as the term variety in s2 of the Plant Variety Rights Act 1987:

‘a cultivar, or cultivated variety, of a plant, and includes any clone, hybrid, stock, or line, of a plant; but does not include a botanical variety of a plant.’

90. While plant varieties are not patentable, claims that include plant genera or species may be allowed. Where there may be doubt as to whether a claim relates to a variety rather than plant genera or species, it may be useful to seek the advice of the Plant Variety Rights Office before making a final decision.

91. The exclusion in s16(4) applies regardless of how the variety is produced. For example a plant variety produced by genetic modification would not be patentable under s16(4). While it is not possible to be definitive in this area, if the claims relate to plants produced by conventional breeding processes, they probably relate to a plant variety rather than genera or species.

92. However, claims to transgenic plants may be allowable unless they are limited to the modification of a particular variety.